Otsuka Pharmaceutical Co., Ltd.

April 27, 2016

FDA Issues Complete Response Letter For Digital Medicine New Drug Application

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Proteus Digital Health (Proteus) today announced that the United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for their Digital Medicine, a drug/device combination product, which combines Otsuka's ABILIFY® (aripiprazole), an atypical antipsychotic, with the FDA-cleared Proteus ingestible sensor embedded in a single tablet at point of manufacture. The NDA was submitted as a system that measures medication adherence to aripiprazole to be indicated for the treatment of schizophrenia, as an acute treatment of manic and mixed episodes associated with Bipolar I Disorder (BP1) and as an adjunctive treatment for Major Depressive Disorder (MDD).

FDA has completed its review and has requested additional information, including data regarding the performance of the product under the conditions in which it is likely to be used, and further human factors investigations. The goal of human factors testing is to evaluate use-related risks and confirm that users can use the device safely and effectively.

"While we are disappointed in the FDA's decision not to approve this Digital Medicine at this time, both Otsuka and Proteus are committed to working with the FDA to address its questions and provide the additional data that has been requested," said Robert McQuade, executive vice president and chief strategy officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "We believe in the potential of this product to help people with serious mental illness manage their daily medication, which remains a serious unmet need."*1

  1. 1Kane JM, Kishimoto T, Correll CU. Nonadherence to medication in patients with psychotic disorders: epidemiology, contributing factors and management strategies. World Psychiatry. 2013;12:216-226